Biosense Webster launches RF balloon ablation catheter in Europe

Biosense Webster, part of Johnson & Johnson MedTech, has launched the HELIOSTAR Balloon Ablation Catheter in Europe – a radiofrequency balloon ablation catheter.

The HELIOSTAR Balloon Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) of the atria and, when used with a compatible multi-channel RF generator, for cardiac ablation.

Europe is home to more than 11 million people living with atrial fibrillation (AF); by 2030, the number of people with AF is expected to increase by up to 70%. In Europe, catheter ablation is a recommended first-line treatment option and is associated with a significant improvement in quality of life and significant reductions in AF burden and AF-related complications.

The HELIOSTAR Balloon Ablation Catheter is fully integrated with the CARTO 3 System, a 3D mapping solution. The HELIOSTAR Balloon Ablation Catheter has a compliant balloon that can conform to varied pulmonary vein anatomy and provides the ability to achieve single-shot pulmonary vein isolation (PVI) in 12 seconds. Use of the HELIOSTAR Balloon Ablation Catheter, with the LASSOSTAR Catheter and CARTO 3 System, may reduce fluoroscopy time and exposure, potentially benefitting both the patient and physician. Shorter procedure time may require less anaesthesia and radiation and may result in less facility time. These time savings may also enable more procedures per day, facilitating patient access. HELIOSTAR Balloon Ablation Catheter is not commercially available in the United States.

Prof. Dr. Gian Battista Chierchia, full professor in cardiology, HRMC, Brussels, Belgium, CMO Electrophysiology Frontiers, said: “The HELIOSTAR catheter is an effective and efficient technology, enabling great results in less procedure time, which has many benefits to both my patients, myself, and my staff. The high single-shot isolation success rate is particularly valuable when it comes to procedural efficiency, and at my institution we’ve been able to reproducibly perform procedures in 15 - 20 minutes.”

The HELIOSTAR Balloon Ablation catheter features ten gold-plated, irrigated electrodes and the amount of power delivered to each electrode can be customised based on anatomical location and known tissue thickness. HELIOSTAR is the only multi-electrode single-shot balloon with the flexibility to perform both circumferential and segmental ablation, enabling personalised PV ablation. The amount of power delivered to each electrode can be controlled independently and the catheter can deliver titrated radiofrequency energy for a customisable workflow.

Prof. Dr. Tillman Dahme, Ulm University Medical Center – Department of Medicine II (Cardiology, Angiology, Pneumology, Critical Care Medicine), Germany, said: “The HELIOSTAR catheter is an exciting addition to my set of tools for delivering customisable, efficient, and effective cardiac ablations. I have performed more than 120 cases with this tool at my institution to date, with an average left atrial procedure time of 35 minutes. As AF prevalence continues to rise and impact more people in Europe and around the world, I am always looking for novel solutions like this to help me deliver better and more personalised treatments for my patients.”

In a multicentre single-arm study, SHINE, the HELIOSTAR Balloon Ablation Catheter was an effective treatment for paroxysmal atrial fibrillation (AF) and isolated targeted pulmonary veins (PV) in 98.8% of patients without the need for focal touch-up. Average time to isolation of each pulmonary vein was 9-12 seconds. In addition, the RADIANCE study demonstrated 86% freedom from documented atrial arrhythmia at 12 months. In September 2021, the first post-approval procedures were successfully performed with the HELIOSTAR Balloon Ablation Catheter at sites across Europe.

Michael Bodner, Ph.D., worldwide president, Biosense Webster, said: “Our goal at Biosense Webster is to utilise the latest science and technology to help electrophysiologists deliver the best possible outcomes for their patients. The launch of the HELIOSTAR Balloon Ablation Catheter in Europe is an exciting milestone as we work together with the EP community to advance safe, effective, and efficient treatment solutions for patients suffering from atrial fibrillation.”